US20140249622A1

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Publication number: US20140249622A1
Application number: US14/278,665
Authority: US
Inventors: Doron Carmi; Marcel Peltier
Original assignee: LABORATOIRES INVALV
Current assignee: LABORATOIRES INVALV
Priority date: 2011-11-17
Filing date: 2014-05-15
Publication date: 2014-09-04
Also published as: US10098736B2; WO2013072496A1; FR2982763A1; EP2779943A1; FR2982763B1; EP2779943B1; WO2013072498A1

Abstract

The implant (12) according to the invention comprises a tubular frame (16), a plurality of distal arms (18) capable of pressing on a first face of a tissue, and a plurality of proximal arms (20) having an end (62) connected to the frame and a free end (64) intended to press on a second face of the tissue to clamp the tissue. The implant comprises a first integral assembly including a first part (38) of the frame and the proximal arms (20), and a second integral assembly including a second part of the frame (40) and the distal arms (18), the first assembly and the second assembly being attached one on top of the other. The first part (38) of the frame is in the form of a proximal sleeve, extending longitudinally between a proximal end (41) and a distal end (43) of the sleeve. The connected end (62) of each proximal arm (20) is connected to the distal end (43) of the proximal sleeve (38), and the free end (64) of each proximal arm (20) extends beyond that distal end (43) of the proximal sleeve (38).

Description

The present invention relates to an implant designed to be placed in a blood flow passage, the implant being deployable between a contracted configuration and a deployed configuration, comprising:

Such an implant is designed to replace a native heart valve, in particular a mitral valve or a tricuspid valve, with an endovalve.
In the case of the mitral valve, the implant is designed to be placed in an atrio-ventricular blood passage of a human or animal heart.
During systole, the blood passage between the left atrium and left ventricle of the heart is interrupted by the closing of a native heart valve present in a mitral system. This valve ensures one-way circulation of the blood flow, avoiding reflux at the end of the ventricular contraction.
The mitral system comprises a mitral annulus, two valve leaflets connected to that annulus, and a sub-valve system comprising chords and piers.
The valve leaflets include an anterior leaflet, or “large mitral valve”, and a posterior leaflet, or “small mitral valve”.
The part connecting the annulus with the large valve is fibrous, while the part connecting the annulus with the small valve is muscular. The large and small valves are connected to the ventricular part by chords, which in turn are connected to piers. In diastole, the two leaflets open to free the passage between the atrium and the left ventricle.
In systole, the ventricular contraction causes a sharp increase in the left intra-ventricular pressure, causing blood to be ejected through the aortic valve. At the same time, the contraction of the piers and tensing of the chords cause the two leaflets to be joined, so as to sealably isolate the left atrial and ventricular cavities.
However, diseases affect the valves and the chords. In particular, the latter may suffer degeneration, thereby allowing reflux or regurgitation.
Furthermore, in case of severe and chronic mitral regurgitation, the underlying left ventricle expands and its contractility decreases, which may lead to the need for heart surgery, even without any symptoms.
To offset these problems, it is known to implant an endovalve between the leaflets delimiting the sick valve. The endovalve is for example made up of a deployable tubular endoprosthesis and a flexible closing member made from a tissue of animal origin. The flexible closing member is permanently fixed in the endoprosthesis.
Such endovalves are generally implantable less invasively than a surgical valve replacement, which limits the risks associated with the implantation of the valve, in particular in terms of mortality.
Known for example from WO 2010/121076 is a mitral implant positioned in an atrio-ventricular blood passage to replace the native valve.
Such an implant includes a plurality of atrial arms and a plurality of ventricular arms positioned across from the atrial arms to clamp the mitral annulus, while pressing on the atrial face of the leaflets of the native valve, plicating it. The ventricular arms are formed by hooks positioned at the ventricular end of the frame and folded toward the atrial end. The atrial arms are formed by V-shaped loops extending across from the ventricular arms, in the vicinity thereof, but moving away from the frame and the atrial arms.
The free ends of the ventricular arms and the atrial arms are positioned separated from each other and are respectively pushed into an atrial face and into a ventricular face of the mitral annulus.
Another example implant is in particular described in WO 2011/057087.
It will be noted that the installation of a mitral implant to replace the native valve may be done by passing through the atrial cavity, or alternatively by passing through the ventricular cavity. This installation is generally done using a suitable deployment tool. The structure of this deployment tool may be different based on the side (atrial or ventricular) through which one passes to perform this installation.
The invention in particular aims to facilitate the installation of a mitral implant, in particular when the latter is installed by passing through the ventricular cavity.
To that end, the invention in particular relates to an implant designed to be placed in a blood flow passage, and to be fixed on a tissue, the implant being deployable between a contracted configuration and a deployed configuration, the implant comprising:

Each proximal arm extends from the distal end of the proximal sleeve, beyond that distal end. Thus, when the proximal sleeve is brought closer to the valve leaflets from the ventricular cavity, the proximal arms are located in front of that sleeve, with the result that they can receive the valve leaflets without being bothered by the sleeve.
In other words, the implant structure as defined above allows greater ease of insertion of the valve leaflets into the receiving space delimited by the proximal arms.
It should be noticed that since the frame is made of the first part and the second part, this frame can be considered as built only when said first and second parts are assembled together.
The implant according to the invention may comprise one or more of the following features, considered alone or according to any technically possible combination:
The proximal arms delimit a space between them for receiving the tissue, the proximal sleeve extending completely outside that receiving space.
The first and second parts of the frame are each formed by a mesh of interlaced threads, for example delimiting polygonal meshes.
The proximal arms delimit a space between them for receiving the tissue, the second part of the frame being in the form of a distal sleeve, with a central axis, said distal sleeve extending longitudinally: partially inside the proximal sleeve, coaxially to the proximal sleeve; partially inside the space for receiving the tissue, such that the tissue is capable of being received between the proximal arms and the distal sleeve; and partially beyond the tissue receiving space.
Optionally, in the deployed configuration, when no outside bias is present, the free end of at least one proximal arm is positioned in contact with the distal arm and/or the frame, the proximal arm including at least one intermediate region extending along and radially separated from the frame to define a longitudinal cavity for receiving the tissue.
In fact, it appears that an implant of the state of the art, for example as described in WO 2010/121076, is not fully satisfactory. In particular, the connecting parts connecting the annulus with the large valve being fibrous, the annular and ventricular arms are planted in a tissue that is not very robust.
The axial fixing of the implant is therefore weakened, and its positioning may evolve over time, in particular under the effect of the blood pressure applied on the valve, causing a secondary movement of the implant.
Furthermore, the fastening of the implant on the entire mitral annulus creates a risk, across from its interior area, of bother for the blood flow across from the left ventricular ejection pathway delimited by that interior area.
In the case mentioned above where the implant according to the invention has at least one proximal arm whereof the free end is positioned in contact with a distal arm and/or the frame, and where the proximal arm includes at least one intermediate region, an implant is obtained designed to be implanted to replace a defective native valve, in particular a mitral valve, that has a simple structure, while offering robust fixing on a tissue of the native valve.
In particular, in the case of a mitral valve, wider fixing is thus offered on the surface of the two leaflets and its two atrial or distal, and ventricular proximal, faces, with an off-centered position of the mitral implant moving away from the interior area of the mitral annulus and advantageously pressing on its posterior area.
Advantageously, the implant according to the invention has at least one proximal arm whereof the free end is positioned both in contact with a distal arm and in contact with the frame. Thus, the proximal arm has several bearing points, with the result that the implant is more stably anchored.
The implant according to the invention may further comprise one or more of the following features, considered alone or according to any technically possible combination:
The intermediate region of each proximal arm has a curved shape, with the convex side oriented radially away from the axis, the immediate region comprising at least one proximal segment diverging radially away from the connected end and at least one distal segment converging radially toward the free end.
At least one proximal arm defines, at its free end, a distal region protruding radially away from the central axis relative to the intermediate region, the distal region being pressed below a distal arm, the stiffness in flexure of the intermediate region preferably being greater than the stiffness in flexure of the distal region.
Each proximal arm has two branches distally converging toward one another to substantially assume the shape of an upside down V in the deployed configuration.
Each distal arm forms a loop protruding transversely relative to the central axis.
The distal arms are adjacent to one another to form a transverse collar perpendicular to the axis in the deployed configuration, the collar advantageously being covered with a skirt made from tissue capable of guiding the blood through the frame.
The radial expanse of a first distal arm in a first annular sector around the axis is greater than the radial expanse of a second distal arm situated in a second annular sector, advantageously greater than 50% of the radial expanse of a second distal arm.
At least one first proximal arm has a first distal region pressed across from a first distal arm, a second proximal arm having a second distal region pressed across from a second distal arm, the radial expanse of the first distal region being greater than the radial expanse of the second distal region.
The proximal sleeve has, when it is separated from the distal sleeve, and when no outside bias is present, a diameter smaller than that of the distal sleeve when no outside bias is present.
Each proximal arm is radially movable away from the central axis from an idle position in contact with a distal arm and/or the frame toward a radially separated position for the insertion of the tissue into the cavity, the proximal arm being elastically biased toward the idle position, or alternatively being biased toward the idle position by any possible mechanical means.
The length of the or each proximal arm, considered between its end connected to the frame and its free end along the axis A-A′, is greater than 50%, advantageously greater than 70%, of the length of the frame, taken between the proximal end and the distal end.
The implant includes a flexible closing member mounted in the inner conduit to selectively close the blood passageway.
The implant is a single piece made integrally.
The intermediate region defining the longitudinal cavity is situated between the connected end and the point of contact of the free end with the frame and/or the distal arm.
The distal region is situated axially opposite the intermediate region relative to the point of contact of the free end with the frame and/or the distal arm.
The invention also relates to a treatment device for a blood flow passage, characterized in that it includes:

- an implant as defined above;
- a tool for deploying the implant, the implant being mounted in its contracted configuration in the deployment tool.

The treatment device according to the invention may include one or more of the following features, considered alone or according to any technically possible combination:
The device includes a locking head delimiting at least one housing for receiving the frame, a stent engaged in the frame, an inner sheath for retaining each distal arm in an axial configuration positioned around the frame, and an outer sheath for pressing each proximal arm against the outer sheath, the inner sheath being positioned around the frame and each distal arm to keep the distal arm in an axial configuration.
The device includes a locking head delimiting at least one housing for receiving the frame and retaining each distal arm in an axial configuration, a stent engaged through the frame, an outer sheath for pressing the proximal arm against the frame, the frame and the distal arms being substantially immobile relative to the stent during the movement of the outer sheath, the device further including an intermediate wall protruding from the head in the outer sheath to keep the proximal arms in position and separate them from the distal arms.
The device includes: a locking head delimiting at least one housing for receiving the frame, a stent engaged in the frame, comprising a distal end fixed to the locking head, an inner sheath for retaining the second part of the frame in the contracted configuration, the inner sheath being positioned around the second part of the frame, an outer sheath for pressing each proximal arm against the outer sheath, the outer sheath being positioned around the proximal arms, and an intermediate sheath for keeping the first part of the frame in the contracted configuration, the intermediate sheath being positioned around the first part of the frame, said first part being positioned between the inner sheath and the intermediate sheath.
The invention also relates to a method for placing an implant in a blood flow passage and to fix it on leaflets of a native valve, between an atrial cavity and a ventricular cavity of a hearth, said leaflets having an atrial face and a ventricular face, and said implant being deployable between a contracted configuration and a deployed configuration, the implant comprising:

Optionally, the method uses a tool for deploying the implant, the implant being mounted in its contracted configuration in the tool, the tool including:

Optionally:

Optionnally:

- said other sheath, and the proximal sleeve in the contracted configuration within the other sheath, are introduced in the ventricular cavity from a first way,
- the inner sheath, and the distal sleeve in the contracted configuration within the inner sheath, are introduced in the atrial cavity, from a second way different from said first way.

The native valve is chosen between a mitral valve or a tricuspid valve.

The invention will be better understood upon reading the following description, provided solely as an example, and done in reference to the appended drawings, in which:

FIG. 1 is a side view of a first implant according to the invention, in a deployed configuration;

FIG. 2 is a diagrammatic view, in partial cross-section along a median axial plane, of the implant ofFIG. 1;

FIG. 3 is a developed view of the lower part of the implant ofFIG. 1 in the deployed configuration of the implant;

FIG. 4 is a view similar toFIG. 3 of an upper part of the implant in the contracted configuration of the implant;

FIG. 5 is a side view illustrating the side profile of the side proximal arms;

FIG. 6 is a top view of the implant shown inFIG. 1, illustrating the distal collar;

FIG. 7 is a view of a treatment device, in which the implant ofFIG. 1 is loaded in a contracted configuration;

FIGS. 8 to 11 illustrate different deployment phases of the implant ofFIG. 1 in an atrio-ventricular passage;

FIG. 12 is a view similar toFIG. 7 of an alternative treatment device according to the invention;

FIGS. 13 to 15 are diagrammatic views similar toFIGS. 8 to 11 illustrating different deployment phases using the device ofFIG. 12;

FIG. 16 diagrammatically shows, in axial cross-section, a treatment device according to another alternative embodiment, in which the implant is loaded in a contracted configuration;

FIGS. 17 to 22 are diagrammatic views similar toFIG. 16, showing the treatment device ofFIG. 16 in different deployment phases;

FIG. 23 is a diagrammatic profile view of an implant according to one alternative embodiment of that ofFIGS. 3 and 4, positioned in a blood flow passage;

FIGS. 24 to 26 are diagrammatic views similarFIGS. 16 to 22, showing the treatment device comprising the implant ofFIG. 23, in different deployment phases of that implant;

FIGS. 27 and 28 are diagrammatic views similar toFIGS. 23, showing the implants according to respective alternative embodiments, positioned in a blood flow passage;

FIGS. 29 and 30 are diagrammatic profile views of a first part of an implant according to respective alternative embodiments;

FIGS. 31 and 32 are views similar toFIGS. 3 and 4, respectively showing a first part and a second part of the implant according to another alternative embodiment;

FIGS. 33 to 38 are diagrammatic profile views of an implant during different deployment phases of a method for placing the implant according to a second embodiment; and

FIGS. 39 to 44 are diagrammatic profile views of an implant during different deployment phases of a method for placing the implant according to a third embodiment.

Afirst treatment device10 according to the invention is illustrated byFIG. 7.

Thedevice10 includes animplant12, shown in detail inFIGS. 1 to 6, and atool14 for deploying theimplant12 designed to position and deploy theimplant12 in a blood flow passage, for example a passage situated in the heart of a patient.

Theimplant12 is advantageously an endovalve, in particular a heart valve designed to replace a defective native valve. The endovalve is advantageously an atrio-ventricular valve, designed to replace the native mitral valve situated between the left atrium and left ventricle, so as to allow a one-way flow of the blood flow between the atrial cavity and the left ventricular volume.

Alternatively, the endovalve is an atrio-ventricular valve designed to replace the heart valve in the tricuspid position, thus the native valve is for instance a tricuspid valve. In this case, it should be noticed that the implant may be brought towards the tricuspid valve through a ventricular way, or in a variant through the right jugular vein.

As illustrated byFIGS. 1 and 2, theimplant12 includes atubular frame16, a plurality ofdistal arms18 designed to form a distal pressing on a distal face of a valve leaflet, and a plurality ofproximal arms20 designed to receive a proximal face of the leaflets of the native valve to attach on that valve.

In the case where the native valve is the mitral valve, the distal face makes up the atrial face and the proximal face makes up the ventricular face.

Theimplant12 further advantageously includes a closingmember24 with a base of a tissue, in particular synthetic or natural tissue, such as bovine, equine and/or porcine pericardium. The closingmember24 is shown diagrammatically in dotted lines inFIG. 2. It is designed to ensure the one-way flow of blood through theimplant12.

Theimplant12 generally extends along a central axis A-A′. It can be deployed between a contracted configuration, which it occupies when it is positioned in thedeployment tool14, and a deployed configuration, which it occupies when it is situated outside thedeployment tool14.

In one advantageous alternative, theimplant12 is self-expandable, i.e., its deployed configuration constitutes its idle position, theimplant12 in its contracted configuration being biased toward its deployed configuration.

Theframe16, thearms18 and thearms20 are for example formed from a stainless steel with elastic properties. Alternatively, these elements are formed with a base of shape memory metal such as Nitinol or a flexible polymer fiber.

Thetubular frame16 is formed by atubular body30 inwardly defining ablood flow conduit32.

Thebody30 is advantageously made with a base of a plurality offiliform elements34 or a single piece forming a peripheral wall with axis A-A′ and delimitingpassage openings36 between them.

Thebody30 comprises afirst part38, also called proximal sleeve, and asecond part40, also calleddistal sleeve40. It should be noticed that since thebody30 is made of thefirst part38 and thesecond part40, thisbody30 can be considered as etablished only when said first38 and second40 parts are assembled together.

In the example illustrated inFIGS. 3 and 4, theproximal sleeve38 is made up of undulatingfiliform elements34, and thedistal sleeve40 is formed by undulatingfiliform elements34. A plurality oflongitudinal members42 connect theproximal sleeve38 to thedistal sleeve40.

Each

sleeve

38,40 comprises a plurality of rows of undulatingfiliform elements34 connected to each other by longitudinal tabs.

Alternatively, theframe16 is formed by a mesh of interlaced threads for example delimiting polygonal meshes.

In this example, theproximal sleeve38 and theproximal arms20 form a first integral assembly, shown inFIG. 3. This assembly is attached on a second integral assembly shown inFIG. 4, and formed by themembers42, thedistal sleeve40 and thedistal arms18.

The first assembly and the second assembly are attached one on top of the other, then optionally secured using sutures or another connecting means.

Advantageously, when theproximal sleeve38 is separated from thedistal sleeve40, and when no outside bias is present, said proximal sleeve has a diameter smaller than that of thedistal sleeve40 when no outside bias is present. Thus, when thedistal sleeve40 is deployed inside theproximal sleeve38, it exerts a radial force on an inner surface of thatproximal sleeve38, that radial force being sufficient to provide the connection between theproximal sleeve38 and thedistal sleeve40.

To that end, it will be noted that thedistal sleeve40 is for example made from stainless steel with elastic properties. For example, thedistal sleeve40 is deployed by inflating an inflatable balloon.

Alternatively, thedistal sleeve40 may be made from a shape memory metal, such as nitinol (Nickel/Titanium).

Furthermore, thedistal sleeve40 has a length, in the direction of the axis A-A′, greater than the length of theproximal sleeve38. Thus, theproximal sleeve38 can be positioned in different positions on thedistal sleeve40, in particular depending on the predetermined configuration of the blood flow passage designed to receive theimplant12.

As in particular shown inFIG. 3, theproximal sleeve38 extends longitudinally between aproximal end41 and adistal end43 of the sleeve. Eachproximal arm20 extends between an end62 connected to thedistal end43 of theproximal sleeve38, and afree end64. Thus, eachproximal end20 extends in the direction of the central axis A-A′ beyond thatdistal end43 of theproximal sleeve38.

Such a configuration in particular makes it possible to facilitate the insertion of the valve leaflets into a receivingspace39 of those valve leaflets delimited between theproximal arms20, as will be described later in reference toFIGS. 16 to 22 and24 to26.

In particular, it will be noted that theproximal sleeve38 extends completely outside that receivingspace39, with the result that it does not hinder the insertion of the valve leaflets in the receivingspace39.

The transverse section of thetubular frame16 and that of theconduit32 is advantageously substantially constant.

Theconduit32 extends through theframe16 along the axis A-A′. It emerges axially at aproximal end44 of theframe16 and adistal end46 of theframe16. It will be noted that theproximal end44 of theframe16 may be formed by theproximal end41 of theproximal sleeve38, or by the proximal end of thedistal sleeve40, based on the relative arrangement of those proximal38 and distal40 sleeves. Furthermore, thedistal end46 of theframe16 is generally formed by the distal end of thedistal sleeve40.

In the contracted configuration, the section of theconduit32 is minimal. The length L1 of thetubular frame16, considered along the axis A-A′ between its

ends

44,46, is then maximal. On the contrary, in the deployed configuration, the length L1 of thetubular frame16 is minimal and the transverse section of theconduit32 is maximal.

In the deployed configuration, the length L1 of theframe16, considered between its

ends

44,46 along the axis A-A′, is greater than10 mm and is in particular comprised between 5 mm and 45 mm to adapt to a variety of anatomical configurations.

As illustrated byFIGS. 1,2 and4, thedistal arms18 extend radially from thetubular frame16 in the vicinity of thedistal end46, for example at a distance of less than 10% of the length L1 of the frame relative to thedistal end46.

Thedistal arms18 are distributed at the periphery of theframe16. The number of distal arms is greater than 2, and is in particular comprised between 5 and 20.

In the example illustrated inFIG. 4, thearms18 extend continuously over the entire periphery of thetubular frame16 around the axis A-A′ while being adjacent to one another.

Eachdistal arm18 is formed by a

loop

50A,50B having twoinner segments52 shared with an adjacentdistal arm18, and one uniqueouter segment54 folded in a loop.

As illustrated byFIGS. 1 and 4, thedistal arms18 are movable between an axial position, shown inFIG. 4, when theimplant12 is in its contracted configuration, and a transverse position, shown inFIG. 1, when theimplant12 is in its deployed configuration.

In the transverse position, when idle, without any outside bias, eachdistal arm18 extends perpendicular to the axis A-A′.

In that position, the expanse e1 of eachdistal arm18, taken between theframe16 and the free end of thearm18, perpendicular to the axis A-A′, is smaller than 50% of the length L1.

Alternatively, the expanse e1 of thedistal arms18 may be even larger, in particular greater than 50% of the diameter of thetubular frame16. Such an expanse makes it possible to overflow beyond the mitral annulus and press on the walls of the left atrium.

Advantageously, each of thedistal arms18 may include a distal region, more flexible than a proximal region forming a slightly concave tab. The concave side is then oriented toward the left atrium and the tab is pressed beyond the mitral annulus on the walls of the left atrium. In this configuration, eachdistal arm18 advantageously has a radial expanse greater than 80% of the length L1 of theframe16.

As illustrated byFIG. 6, the radial expanse e1 of thearm18 in a first angular sector S1 is also larger than the radial expanse e1 of thearms18 situated in the second angular sector S2. This makes it possible to adapt to the anatomical configuration of the seat of the mitral valve, in particular when the native valve is the mitral valve.

In the deployed configuration, thedistal arms18 thus form a continuousannular collar60 designed to press on the distal incline of the native valve, on the atrial incline, on the annulus and on the wall of the atrium when the native valve is mitral valve.

Advantageously, a skirt made from tissue, in particular Dacron or another synthetic biological tissue, covers thecollar60. This skirt thus provides sealing between the left atrium and the left ventricle at the perimeter of thetubular frame16. The skirt is advantageously sewn on thedistal arms18 and may optionally radially overflow past thecollar60 to press on the atrial face of the mitral annulus and on the inner faces of the walls of the left atrium.

The skirt may also cover the inner surface of theframe16 as far as the closingmember24 to guarantee the passage of blood through the closingmember24 without any risk of leak through the wall of theframe16.

In the example shown in the Figures, theimplant12 includes a plurality ofproximal arms20 angularly spaced apart from one another around the axis A-A′.

The number ofproximal arms20 is smaller than or equal to the number ofdistal arms18. In this example, the number ofproximal arms10 is greater than 2, and is in particular comprised between 4 and 10.

Eachproximal arm20 extends axially between an end62 connected to theframe16, situated in the vicinity of theproximal end44, and afree end64 designed to press against adistal arm16 or against theframe16 when theimplant12 is in its deployed configuration.

The distance separating theproximal end44 of theframe16 from theconnected end62 along the axis A-A′ is smaller than 20% of the length L1 of theframe16.

Eachproximal arm20 thus has a length, considered parallel to the axis A-A, along theframe16, greater than 50%, advantageously greater than 70% of the length L1 of thetubular frame16, considered between the proximal end and the distal end.

As illustrated byFIG. 5, eachproximal end20 includes, between itsconnected end62 and itsfree end64, at least oneintermediate region66 extending along and radially away from theframe16 to define alongitudinal cavity68 for receiving a valve leaflet.

Advantageously, at least oneproximal arm20 further includes adistal region70 forming an outer tab pressed below adistal arm18, or on theframe16.

As illustrated byFIGS. 1 and 5, at least onearm20 thus has an S-shaped profile with an outwardly curvedintermediate profile66 relative to the axis A-A′ and adistal region70 protruding radially away from the axis A-A′ relative to theintermediate region66.

As illustrated byFIGS. 1 and 5, theintermediate region66 comprises aproximal segment72 diverging radially away from the axis A-A extending from theconnected end62, and adistal segment74 converging toward the axis A-A′ while moving along the axis A-A′ from theconnected end62 toward thefree end64.

The maximum distance d1 radially separating theintermediate region66 of the outer enclosure from thetubular frame16 is greater than 10% of the diameter of the tubular frame. That distance is advantageously smaller than 40% of the diameter of thetubular frame16.

Thedistal region70 forms a tab that converges radially outward from the convergingsegment74.

In the deployed configuration of theimplant12, eachdistal region70 protrudes radially below adistal arm18.

Thedistal region70 has a flexibility in flexure greater than that of theintermediate region66. The filiform element making up thedistal region70 for example has a maximum thickness smaller than the maximum thickness of the filiform element forming theintermediate region66.

The maximum radial expanse of thedistal region70, considered between the end of thedistal segment74 and thefree end64 of thedistal region70, is greater than the radial expanse of theintermediate region66.

Furthermore, theproximal arms20 situated in the first angular sector S1 include adistal region70 with a radial expanse greater than the radial expanse of thedistal regions70 of theproximal arms20 situated in the second angular sector S2, connected with the length of thedistal arms18.

According to the invention, in the deployed configuration of theimplant12, eachproximal arm20 is radially deformable, between a radially contracted idle position and a position radially separated from the idle position, for the insertion of the leaflets of the native valve into thecavity68.

In the idle position, eachproximal arm20 is pressed against theframe16 and/or against adistal arm18 without any outside bias.

In the deployed position, eacharm20 is elastically returned toward its idle position, the idle position constituting its stable position.

The length of the convergingsegment74, considered along the axis A-A′, is greater than the length of the divergingsegment72. The length of thedistal region70 is smaller than the length of the convergingsegment74 and the length of the divergingsegment72.

In the example shown inFIGS. 1 and 3, eacharm20 is formed bylinear branches78 forming an upside down V converging distally. Atransverse end segment80 connects thebranches78 to each other. Thedistal region70, when it is present, protrudes from theend segment80.

Thebranches78 of two adjacentproximal arms20 are in contact with one another at their connected ends62.

The maximum angle formed by thebranches78 is for example smaller than 45°, and is in particular smaller than 30°.

In the example shown in the Figures, eachproximal arm20 is further provided with anchoringelements82 in a valve leaflet each formed by an apex protruding toward theproximal end44.

Traditionally, the closingmember24 is formed by flexible flaps (not shown) fixed on theframe16 in theconduit32. Each flap is for example formed by a polymer film or a layer of organic film such as the pericardium of an animal, in particular calf pericardium. The flaps are deformable in a closing position, in which the blood flow from the proximal end toward the distal end is prevented, and a blood flow passage position, in which the flaps are separated from each other.

The flaps are partially fixed on theframe16 along a suture line. The distal edge of the flaps is situated axially away from the distal edge of the frame. The distance axially separating the distal edge of theframe16 from the distal edge of the flaps is for example greater than 10%, in particular substantially equal to 20% of the length L1.

As illustrated byFIG. 7, thedeployment tool14 for thefirst device10 includes aninner rod90 provided with ahead92 for maintaining one end of theimplant12, astent93 mounted coaxially slidably on therod90, aninner sheath94 mounted slidably relative to thestent93 and anouter sheath96 mounted slidably around theinner sheath94, along an insertion axis B-B′.

Thestent93 and the

sheath

94,96 are slidably movable along the axis B-B′, independently of one another, and relative to therod90.

Locking members (not shown) are provided between the rod and thestent93, between thestent93 and the

sheath

94,96 to avoid spontaneous sliding of thestent93, the outer96 and inner94 sheaths. This makes it possible to proceed by successive steps with the removal of theouter sheath96, removal of theinner sheath94, and the release of theproximal end44. Theinner stent93 includes anaxial locking stop98 extending across from thehead92. Thestop98 is designed to lock thedistal end46 of theimplant12.

Thehead92 delimits ahousing100 for receiving theproximal end44 of theimplant12, in which theproximal end44 is kept radially compressed. Thisend44 is also axially fixed relative to thestent93.

Thestent93 and theinner sheath94 delimit an innerannular space102 designed to receive theframe16 and thedistal arms18. Theouter sheath96 delimits an outerannular space104 designed to receive theproximal arms20.

Thestent93 is provided with at least one

angular indexing stop

105A,105B for theimplant12 to angularly fix theimplant12 relative to thestent90 in theinner sheath94 around the axis of thestent90. The or each indexing stop105A,105B is advantageously radiopaque to identify the arrangement ofatrial arms20 with unequal sizes.

Thus, in the example shown inFIG. 7, thestent93 includes two diametrically opposite stops105A,105B axially offset along the axis B-B′.

Thestop105A situated furthest from thehead92 is designed to receive theproximal arms18 with the largest expanse e1, while thestop105B situated closest to the head is designed to receive theproximal arms18 with the smallest expanse e1. The operator of the device can thus orient the implant during its placement in the blood flow passage.

It is thus possible to place the longestdistal arms18 in the posterior area of the mitral annulus when theimplant12 is designed to replace the mitral valve.

In the contracted configuration, when theimplant12 is received in thedeployment tool14, the length of theframe16 is maximal, and its outer diameter is minimal. Thedistal arms18 then occupy their axial position, substantially parallel to the axis A-A′.

Theproximal arms20 are pressed axially along the axis A-A′. The outer diameter of theimplant12 is then minimal.

In this configuration, theframe16 is received in the innerannular space102 separating thestent93 from theinner sheath94. It is kept in position by thesheath94. Thedistal arms18 are placed in contact with thestop98, or in the vicinity thereof in the axial position.

Theproximal arms20 are pressed against theinner sheath94 in the outerannular space104. Theproximal end44 of theframe16 protrudes in thehousing100 of thehead92 and is axially fixed relative to thestent93. Thehead92 and the rod50 are axially locked relative to thestent93, thehead92 being close to thestop98.

When theimplant12 must be positioned, in particular to replace a native valve, it is inserted between theleaflets110 of the native valve around the seat112 of the valve, as shown inFIG. 8. This insertion may be done, using the device ofFIG. 7, through the transatrial approach, passing through the left atrium.

Thehead92 and the downstream part of thetool14 are inserted into the left ventricle, beyond theleaflets110, so that the entire length of theproximal arms20 is positioned in the left ventricle beyond theleaflets110 of the valve.

Then, theouter sheath96 is retracted axially away from thehead92 relative to theinner sheath94 and relative to thestent93 to gradually expose theproximal arms20.

When thearms20 are completely exposed, theouter sheath96 is then moved again toward thehead92 so that itsfree edge114 becomes intercalated between thearms20 and theframe16, so as to separate thearms20 from the contracted idle position.

Thearms20 then go into the deployed position shown inFIG. 8.

In that position, theleaflets110 of the native valve are intercalated between theouter sheath96, thetubular frame16 and theproximal arms20 to be received in thecavities68.

Next, thetool14 is moved toward the left atrium to press theventricular arms20 against the ventricular face of theleaflets110 and anchor theapices82 in theleaflets110.

Once that is done, thesheath96 is once again removed, as shown inFIG. 9. Under the effect of the elastic return force of theproximal arm20 toward its idle position, theproximal arms20 retract toward theframe16 and thus clamp theleaflets110 robustly.

The length of theproximal arms20 being greater than 50% of the length of theframe16, theleaflets110 are maintained over a large length against theframe16. They adopt a substantially axial configuration, parallel to the axis of theframe16.

Then, theinner sheath94 is retracted relative to thestent93 to gradually expose theframe16, then thedistal arms18.

As illustrated byFIG. 10, this causes the partial radial deployment of theframe16 and the radial deployment of thedistal arms18 toward their transverse position to bear on the atrial face of theleaflets110.

Once this is done, the axial fastening between thestent93 and theproximal end44 is released by axial movement of therod90 and thehead92 away from thestop98. Theframe16 is completely deployed. Thestent93 and thehead92 and the rod91 are then removed from the patient through theinner conduit32.

In the deployed configuration shown inFIG. 11, thedistal arms18 thus form a transverseannular collar60 pressing robustly on the atrial face of theleaflets110, and on the atrial face of the mitral annulus in the posterior area and optionally on the atrial wall.

Theproximal arms20 are then biased toward their idle position. The curvedintermediate region66 extending substantially away and across from theframe16, over a substantial length of theframe16, is perfectly configured to receive thenative valve leaflet110 and press it against theframe16. The elastic biasing force of eachproximal arm20 toward its idle position applies robust clamping on eachleaflet110, ensuring effective and robust reception of theimplant10 in the native valve. That is the case even if the native valve has a fibrous structure and a tissue that is not very robust.

The particular axial configuration of theproximal arms20, each defining acavity68 for receiving the valve leaflets over significant length relative to the length of theimplant12, and the distal closing of thecavity68 by an annulardistal collar60 that is transverse relative to the axis A-A′, contribute to ensuring robust fixing of theleaflets110. Theimplant10 is furthermore easy to implant and safe.

Advantageously, the robust fixing of theimplant12 is obtained without any radial force on the entire mitral annulus, which avoids expansion of the mitral annulus and therefore worsening of the regurgitation in light of the asymmetrical radial expanse of the distalproximal arms18; thetubular frame16 is implanted in an off-centered manner advantageously to press on the mitral annulus in the posterior area, which moves away from the anterior area and avoids the risk of closing of the left ventricular ejection pathway.

Each of the twonative leaflets110 is advantageously clamped on these two atrial and ventricular faces by thedistal arms18 and theproximal arms20, respectively. Additionally, the mitral annulus is advantageously clamped in the rear area by thedistal arms18 and theproximal arms20. This makes it possible to offset the axis of theframe16 transversely relative to the center of the mitral annulus and to prevent the proximal part of the frame from disrupting the blood flow of the left ventricular ejection pathway.

Theimplant12 essentially being fixed on the native leaflets,distal arms18 andproximal arms20, it is not necessary to have complete pressing on the mitral annulus, which makes it possible to eliminate the size of that annulus for implantation of theimplant12. Theimplant12 then forms a reducer that has a frame diameter advantageously smaller than the diameter of the mitral annulus in which it is imported. This is equivalent to the formation of a mitral funnel, where the distal section line corresponds to the perimeter of the native mitral annulus and the proximal section line corresponds to the diameter of the tubular frame.

The blood is then guided through the closingmember24 by means of the skirt.

Asecond treatment device210 receiving animplant12 is illustrated byFIG. 12. Unlike thedevice10 shown inFIG. 7, thisdevice210 is designed to be implanted through the left ventricle, then through the left atrium by the apex of the heart, in its deployed form.

In this device, thedistal arms18 are received in thehousing100 of thehead92 and are axially fixed relative to thestent93. The device is provided with nointermediate sheath94. Anintermediate wall220 extends from thehead92 to keep theproximal arms20 in position and separate them from thedistal arms18.

Theimplant12 contained in thedevice210 is deployed from the left ventricle toward the left atrium through the native valve. Then, theouter sheath96 is retracted to expose theproximal arms20 as previously described. If theimplant12 is not correctly positioned, theouter sheath96 may be moved again toward thehead98, so as to once again cover theproximal arms20 and place thosearms20 back in theouter sheath96.

The angular positioning of theimplant12 is obtained owing to the

radiopaque stops

105A,105B shown inFIG. 13.

Thehead98 is then retracted relative to thestent93 so that theintermediate wall220 cooperates with theproximal arms20 and separates them from their idle position. As illustrated byFIG. 13, theproximal arms20 are then moved to insert theleaflets110 into thecavities68.

As previously specified, the axis of theframe16 is offset relative to the center of the mitral valve, owing to the size difference between thedistal arms18.

Once theproximal arms20 are housed against the ventricular face of theleaflets110 of the valve (FIG. 14), thehead92 is once again moved jointly with therod90 relative to thestent93 toward the atrium to allow thedistal arms18 to be deployed as illustrated byFIG. 15.

Another treatment device, receiving animplant12, is shown inFIG. 16. In this figure, and the following figures, the elements similar to those of the previous figures are designated using identical references.

As previously indicated, theimplant12 includes a first integral assembly including theproximal sleeve38 of the frame and theproximal arms20, and a second integral assembly including thedistal sleeve40 of the frame and thedistal arms18.

Theproximal sleeve38 extends, along the central axis A-A′, between itsproximal end41 and itsdistal end43. Theconnected end62 of eachproximal arm20 is connected to thedistal end43 of theproximal sleeve38, and thefree end64 of eachproximal arm20 extends in the direction of the central axis A-A′ beyond thatdistal end43 of theproximal sleeve38.

As before, thedeployment tool14 for the device includes the inner rod, provided with thehead92 for maintaining one end of theimplant12, and thestent93 mounted slidingly coaxially on the rod.

Thedeployment tool14 further includes aninner sheath94, slidably mounted relative to thestent93, anintermediate sheath95 slidably mounted around theinner sheath94, and anouter sheath96 slidingly mounted around theintermediate sheath95.

Thestent93 and the

sheaths

94,95,96 are slidably movable, independently of one another, and relative to the rod.

sheaths

94,95,96 to prevent spontaneous sliding of thestent93, the outer96, intermediate95 and inner94 sheaths. This makes it possible to proceed through successive steps with the removals of theouter sheath96, theintermediate sheath95 and theinner sheath94, and the release of the proximal end.

Thehead92 delimits thehousing100 for receiving theproximal end44 of theimplant12, in which theproximal end44 is kept radially compressed. Thisend44 is also axially fixed relative to thestent93.

Thestent93 and theinner sheath94 delimit, between them, the innerannular space102 designed to receive thedistal sleeve40 and thedistal arms18. Thus, thedistal sleeve40 is kept in the retracted configuration by thatinner sheath94.

Theinner sheath94 and theintermediate sheath95 delimit, together between them, an intermediateannular sheath103, designed to receive theproximal sleeve38. Thus, theproximal sleeve38 is kept in the retracted configuration by thatintermediate sheath95.

Theouter sheath96 and theintermediate sheath95 delimit, between them, the outerannular space104, designed to receive theproximal arms20. Thus, eachproximal arm20 is pressed against theouter sheath96.

When theimplant12 must be positioned, in particular to replace a native valve, it is inserted between theleaflets110 of the native valve around the seat112 of the valve. This insertion may be done, using the device ofFIG. 16, by passing through the left ventricle, as will be described below in reference toFIGS. 17 to 22.

As shown inFIG. 17, thehead92 and the downstream part of thetool14 are inserted into the atrial cavity, beyond the mitral annulus, such that thedistal arms18 are positioned in the atrial cavity beyond the mitral annulus.

Theouter sheath96 is axially retracted away from thehead92 relative to theintermediate sheath95, theinner sheath94 and thestent93, to expose thedistal arms18, which are then deployed. Thetool14 is then moved toward the left ventricle to press thedistal arms18 against the atrial face of theleaflets110.

As shown inFIG. 18, theouter sheath96 is again axially retracted to expose theproximal arms20. The latter, which would have pressed against thatouter sheath96, are then deployed, in particular by elasticity. The separation of theproximal arms20 is sufficient for theleaflets110 to be found across from the receivingspace39 defined between thoseproximal arms20.

As shown inFIG. 19, it is then sufficient to move theproximal sleeve38 and theintermediate sheath95 surrounding it toward theleaflets110. Theseleaflets110 are thus inserted into the receivingspace39 defined between theproximal arms20. Because theproximal arms20 extend beyond thedistal end43 of theproximal sleeve38, thisproximal sleeve38 does not hinder the insertion of theleaflets110 into the receivingspace39.

Once theproximal sleeve38 is in position, theinner sheath94 is retracted so as to release thedistal sleeve40. Thisdistal sleeve40 being positioned inside theproximal sleeve38, it is kept in the contracted configuration by thatproximal sleeve38, which in turn is kept in the contracted configuration by theintermediate sheath95.

By deploying inside theproximal sleeve38, thedistal sleeve40 becomes connected to thatproximal sleeve38.

It will be noted that in this position, theleaflets110 of the native valve are intercalated between thedistal sleeve40 and theproximal arms20.

Once the proximal38 and distal40 sleeves are thus connected, theintermediate sheath95 is retracted, so as to release theproximal sleeve38, as shown inFIG. 21.

Theproximal sleeve38 then expands radially as far as its deployed configuration, as well as thedistal sleeve40 inside that deployedproximal sleeve38.

Once that is done, the axial fastening between thestent93 and theproximal end44 is released. Thestent93, thehead92 and the rod are then removed outside the patient through the inner conduit, as shown inFIG. 22.

It will be noted that in this deployed configuration, thedistal sleeve40 extends longitudinally, or partially inside theproximal sleeve38, coaxially to thatproximal sleeve38, partially inside thetissue receiving space39, such that the tissue is received between theproximal arms20 and thedistal sleeve40, and partially beyond thetissue receiving space39.

Theimplant12 may also be inserted using another method, using a device similar to that ofFIG. 16, by passing through the left ventricle, as will be described below in reference toFIGS. 24 to 26.

In these figures, theimplant12 is slightly different from that previously described, in that the shape of itsproximal arms20 is different. However, the previously described insertion method, or that which will be described now, may be used indifferently irrespective of the shape of theproximal arms20 of theimplant12.

Furthermore, thedeployment tool14 does not necessarily include an outer sheath, but preferably only aninner sheath94, keeping thedistal sleeve40 in the contracted position, and another sheath, which we call theintermediate sheath95 to be consistent with the previous embodiment, keeping theproximal sleeve38 in the contracted position.

With the exception of the shape of theproximal arms20, which will be described later in more detail in reference toFIG. 23, and the absence of outer sheath, thedeployment tool14 and the rest of theimplant12 are similar to those described in reference toFIGS. 16 to 22.

In accordance with this other insertion method, theproximal sleeve38 is deployed before thedistal sleeve40. Thus, as shown inFIG. 24, theintermediate sheath95 is axially retracted so as to release theproximal arms20, which are then deployed, in particular by elasticity. The separation of theproximal arms20 thus defines the receivingspace39, which is then completely free.

This receivingspace39 is positioned across from theleaflets110, such that they are inserted into the receivingspace39 by moving thedeployment tool14 toward thoseleaflets110.

It is only after this that thehead92, and theinner sheath94 containing thedistal sleeve40, are moved axially as far as the atrial cavity, beyond the mitral annulus, such that thedistal arms18 are positioned in the atrial cavity beyond the mitral annulus, as shown inFIG. 25.

Next, as shown inFIG. 26, theinner sheath94 is axially retracted away from thehead92 to expose thedistal arms18, which are then deployed. Thetool14 is then moved toward the left ventricle to press thedistal arms18 against the atrial face of theleaflets110.

The position of theproximal sleeve38 is also adjusted, then theinner sheath94 is completely retracted. Thedistal sleeve40 being positioned inside theproximal sleeve38, it is kept in the contracted configuration by theproximal sleeve38, which in turn is kept in the contracted configuration by theintermediate sleeve95. This then leads to a configuration similar to that ofFIG. 20.

Once the proximal38 and distal40 sleeves are thus connected, theintermediate sheath95 is retracted, so as to release theproximal sleeve38, similarly toFIG. 21.

Theproximal sleeve38 then radially deploys as far as its deployed configuration, as well as thedistal sleeve40 inside that deployedproximal sleeve38.

Once that is done, the axial fixing between thestent93 and the proximal end is released. Thestent93, thehead92 and the rod are then removed outside the patient through the inner conduit, similarly to inFIG. 22.

Theimplant12 in the deployed position is shown inFIG. 23. As before, in this deployed configuration, thedistal sleeve40 extends longitudinally or partially inside theproximal sleeve38, coaxially to saidproximal sleeve38, partially inside thetissue receiving space39, such that the tissue is received between theproximal arms20 and thedistal sleeve40, and partially beyond thetissue receiving space39.

It will be noted that the relative position of theproximal sleeve38 with respect to thedistal sleeve40 is chosen during the installation of theimplant12, based on the configuration of the blood flow passage in which thatimplant12 is installed. Thus, according to this embodiment, the proximal38 and distal40 sleeves are capable of sliding relative to one another.

It should be noticed that theproximal sleeve38 is preferably arranged axially apart from theleaflets110, inside the ventricular cavity, as shown inFIG. 23.

According to this alternative embodiment, eachproximal arm20 has a curved shape, with the convex side oriented radially away from the axis A-A′. In particular, theintermediate region66 of eachproximal end20 comprises at least oneproximal segment72 diverging radially away from theconnected end62 and at least onedistal segment74 converging radially toward thefree end64. This curved shape makes it possible to define alongitudinal cavity68 for receiving avalve leaflet110, as previously described.

As previously indicated, the shape of theproximal arms20 does not affect the method for inserting the implant, which may thus be similar to that described in reference toFIGS. 17 to 22, that described in reference toFIGS. 24 to 26, or any other possible insertion method.

Example shapes ofproximal arms20 will now be described, in reference toFIGS. 27 to 30. In these figures, the elements similar to those of the other figures are designated using identical references.

FIG. 27 shows animplant12 according to another alternative embodiment of theproximal arms20.

According to this alternative embodiment, eachproximal arm20 comprises:

- aproximal part106, leaving axially from theconnected end62 toward theproximal end41 of theproximal sleeve38,
- abifurcated part108, connecting theproximal segment106 to adistal part116 of theproximal arm20,
- thedistal part116, leaving axially from thebifurcated part108 toward the distal end of theproximal sleeve38.

Thedistal part116 may also have acurved shape66 like that previously described in reference toFIG. 23.

Theproximal part106 and thebifurcated part108 together define a deeper cavity for theleaflets110. Of course, the length of theproximal part106 may be chosen to be larger or smaller, based on the desired depth of thecavity68.

FIG. 28 shows animplant12 according to another alternative embodiment.

According to this alternative, at least oneproximal end20 has adistal region70 protruding radially away from the central axis A-A relative to theintermediate region66.

More particularly, at least one firstproximal arm20 has a firstdistal region70 pressed across from a firstdistal arm18, and a secondproximal arm20 has a seconddistal region70 pressed across from a seconddistal arm18, the radial expanse of the firstdistal region70 being larger than the radial expanse of the seconddistal region70.

Generally speaking, the radial expanse of thedistal region70 of eachproximal arm20 can be chosen to be larger or smaller, in particular based on the predetermined shape of the blood flow passage designed to receive the implant.

FIG. 29 shows aproximal sleeve38 of animplant12 according to another alternative embodiment.

According to this alternative, eachproximal end20 includes anintermediate part118 elastically deformable in a longitudinal direction of theproximal arm20. To that end, theintermediate part118 is generally in the shape of a spring.

Owing to its longitudinally elastically deformableintermediate part118, the length of eachproximal end20 can vary, and adapt based on the position of theproximal sleeve38 relative to thedistal sleeve40, in particular to ensure optimal clamping of theleaflets110 between theproximal arms20 and thedistal arms18. In other words, in the absence ofleaflets110, it is possible to ensure contact between thefree end64 of at least oneproximal arm20 and onedistal arm18, in the deployed configuration and without any outside bias.

FIG. 3 shows aproximal sleeve38 of animplant12 according to another alternative embodiment.

According to this alternative, eachproximal arm20 includes anintermediate part120 folded so as to form an axial return delimiting a hollow122. This hollow122 is designed to form a cavity for theleaflets110.

FIGS. 31 and 32 show animplant12 according to another alternative embodiment. In particular, theproximal sleeve38 of theimplant12 is shown inFIG. 31, and thedistal sleeve40 inFIG. 32.

Theproximal sleeve38 is made up offiliform elements34 arranged in a grid, for example forming diamond-shaped meshes.

As in particular shown inFIG. 31, theproximal sleeve38 extends longitudinally between aproximal end41 and adistal end43 of the sleeve. Eachproximal arm20 extends between an end62 connected to thedistal end43 of theproximal sleeve38, and afree end64. Thus, eachproximal arm20 extends in the direction of the central axis A-A′ beyond thatdistal end43 of theproximal sleeve38.

According to this alternative embodiment, at least oneproximal arm20 has a length greater than that of at least one other proximal arm. Alternatively or in combination with said greater length, at least oneproximal end20 has aconnected end62 with a smaller width than that of theconnected end62 of at least one otherproximal arm20. Thus, the shapes of theproximal arms20 may be adapted to the predetermined configuration of the blood flow passage designed to receive theimplant12.

Furthermore, thedistal sleeve40 is made up of undulatingfiliform elements34. It will be noted that thisdistal sleeve40 has an axial length greater than that of the distal sleeve that was described in reference toFIG. 4.

Theproximal sleeve38 is designed to be attached on thedistal sleeve40, and it is capable of sliding along thedistal sleeve40 until it is positioned in an optimal position relative to thatdistal sleeve40, based on the configuration of the blood flow passage designed to receive theimplant12.

In the example shown inFIG. 32, thedistal arms18 extend continuously over the entire periphery of thedistal sleeve40 around the axis A-A′ while being adjacent to one another.

Eachdistal arm18 is formed by a

loop

As before, thedistal arms18 are movable between an axial position, shown inFIG. 32, when theimplant12 is in its contracted configuration, and a transverse position, when theimplant12 is in its deployed configuration.

The shape and length of thedistal arms18 may vary from one arm to another, as shown inFIG. 32, in particular in order to adapt to the predetermined configuration of the blood flow passage designed to receive theimplant12.

It will be noted that the invention is not limited to the embodiments previously described, but may assume various alternatives without going beyond the scope of the claims.

In particular, it is possible to provide all sorts of adapted shapes for theproximal arms20 and/or thedistal arms18.

For example, as an alternative to the upside down V-shapedproximal arms20 previously described, theconnected end62 of which has a width larger than that of thefree end64, it is possible to provide at least one proximal arm with a flared shape, whereof theconnected end62 has a width smaller than that of thefree end64.

It is also alternatively possible to provide at least oneproximal arm20 with a rounded, half-circle or half-oval shape.

It also will be noted that other insertion method can be considered.

For instance, a treatment device similar to the treatment device ofFIG. 24 also allows an insertion according to the following steps, shown onFIGS. 33 to 38.

First, the distal end of thetool14, including theimplant12 in the contracted configuration, is inserted in the ventricular cavity.

Then, as shown inFIG. 33, saidother sheath95 is axially retracted so as to release theproximal arms20, which are then deployed, in particular by elasticity. The separation of theproximal arms20 thus defines the receivingspace39, which is then completely free. It should be noticed that theproximal arms20 are released before thebody30 be constituted. Indeed, theproximal arms20 are released before theproximal sleeve38 be assembled with thedistal sleeve40.

Then, as shown onFIG. 34, theinner sheath94 containing thedistal sleeve40, is moved axially as far as the atrial cavity, beyond the mitral annulus, such that thedistal arms18 are positioned in the atrial cavity beyond the mitral annulus.

Next, as shown onFIG. 35, theinner sheath94 is axially retracted so as to expose thedistal arms18, which are then deployed. During this step, theatrial sleeve40 is still partially contracted in theinner sheath94.

As shown onFIG. 36, thetool14 is then moved toward the left ventricle to press thedistal arms18 against the atrial face of theleaflets110. In other words, thedistal arms18 apply an axial force against the atrial face of theleaflets110, this axial force being directed from the atrial cavity towards the ventricular cavity.

Then, the receivingspace39 is positioned across from theleaflets110, such that they are inserted into the receivingspace39 by moving thedeployment tool14 toward thoseleaflets110, as shown onFIG. 37. Thus, theproximal arms20 are pressed against the ventricular face of theleaflets110. In other words, theproximal arms20 apply an axial force against the ventricular face of theleaflets110, this axial force being directed from the ventricular cavity towards the atrial cavity. The direction of the force applied by theproximal arms20 is opposed to the direction of the force applied by thedistal arms18.

We remind that theproximal sleeve38 can slide relative to thedistal sleeve40, so that it is possible to choose the relative position of theproximal sleeve38 with respect to thedistal sleeve40, based on the configuration of the blood flow passage in which thatimplant12 is installed.

Thus, the position of theproximal sleeve38 is adjusted, then theinner sheath94 and theother sheath95 are retracted, so that thedistal sleeve40 and theproximal sleeve38 are deployed, as shown onFIG. 38. It should be noticed that thedistal sleeve40 and theproximal sleeve38 can be deployed simultaneously, or, in a variant, thedistal sleeve40 is deployed into theproximal sleeve38 previously to the deployment of thisproximal sleeve38.

After the deployment of theproximal sleeve38 and thedistal sleeve40, saidproximal sleeve38 anddistal sleeve40 are assembled together, thus they form thebody30. In other words, the body30 (thus the tubular frame16) is formed only in the deployed configuration.

Once that is done, the axial fixing between thestent93 and the proximal end is released. Thetool14 is then removed outside the patient through the inner conduit.

Other insertion method can be considered.

More particularly, since theimplant12 is made of two

independent parts

38,40, these two parts may be brought by different ways into the blood flow passage. For instance, a combined retrograde and anterograde procedure could be performed, as shown onFIGS. 39 to 44.

First, afirst part14A of the tool, comprising saidother sheath95, and theproximal sleeve38 in the contracted configuration within theother sheath95, are introduced in the ventricular cavity from a first way.

Then, as shown onFIG. 39, asecond part14B of the tool, comprising theinner sheath94, and thedistal sleeve40 in the contracted configuration within theinner sheath94, is introduced in the atrial cavity, from a second way different from said first way from which the first part of the tool is introduced in the ventricular cavity. Thus, in this procedure, the second part of the tool is not inserted in the atrial cavity through the mitral annulus.

Then, theother sheath95 is axially retracted so as to release theproximal arms20, which are then deployed, in particular by elasticity. The separation of theproximal arms20 thus defines the receivingspace39.

Then, as shown onFIG. 40, theinner sheath94 containing thedistal sleeve40 is moved axially as far as the ventricular cavity, beyond the mitral annulus, such that thedistal arms18 are positioned in the atrial cavity, and thedistal sleeve40 is partially positioned in the ventricular cavity.

Next, as shown onFIG. 41, theinner sheath94 is axially retracted so as to expose thedistal arms18, which thus are deployed. During this step, thedistal sleeve40 is still partially contracted by means of anannular maintainer66 surrounding theatrial sleeve40.

Thedistal arms18 are then pressed against the atrial face of theleaflets110, as shown onFIG. 42. In other words, thedistal arms18 apply an axial force against the atrial face of theleaflets110, this axial force being directed from the atrial cavity towards the ventricular cavity. Then, the receivingspace39 is positioned across from theleaflets110, such that they are inserted into the receivingspace39 by moving thefirst part14A of thedeployment tool14 toward thoseleaflets110, as shown onFIG. 43. Thus, theproximal arms20 are pressed against the ventricular face of theleaflets110. In other words, theproximal arms20 apply an axial force against the ventricular face of theleaflets110, this axial force being directed from the ventricular cavity towards the atrial cavity. The direction of the force applied by theproximal arms20 is opposed to the direction of the force applied by thedistal arms18.

Thus, the position of theproximal sleeve38 is adjusted, then theannular maintainer66 and theother sheath95 are retracted, so that thedistal sleeve40 and theproximal sleeve38 are deployed, as shown onFIG. 44. It should be noticed that thedistal sleeve40 and theproximal sleeve38 can be deployed simultaneously, or, in a variant, thedistal sleeve40 is deployed into theproximal sleeve38 previously to the deployment of thisproximal sleeve38. Once that is done, thetool14 is then removed outside the patient.